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Yêu cầu
Education Bachelor's degree in Pharmacy, Microbiology, Chemistry, Biotechnology, Chemical Engineering, or a related science discipline.
Postgraduate qualification or specialised GMP certification is an advantage.
Work Experience Experience in a GMP environment; sterile manufacturing experience is strongly preferred.
Experience in Aseptic oversight, Environmental Monitoring, or QA/QC roles is a significant advantage.
Technical Knowledge cGMP: 21 CFR Part 210/211, EU GMP, WHO GMP.
Data Integrity – ALCOA+ (FDA, MHRA, WHO Guidance).
Aseptic Process Simulation (Media Fill).
ICH Q9 (Quality Risk Management) and root cause investigation tools (RCA, 5-Why, Fishbone).
Skills Detail observation skills, accurate and contemporaneous documentation.
Audit skills, effective questioning, and risk assessment.
Written reporting skills in both Vietnamese and English.
Teamwork and cross-departmental communication skills.
Proficient in Microsoft Office; Power BI / advanced Excel is an advantage.
Personal Attributes High integrity, independent judgment, unwavering under production schedule pressure.
Meticulous, critical thinking, and strong compliance mindset.
Willing to work shift-based schedules including nights and weekends as required.
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